China Atopic Dermatitis Registry Study
China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
Studieoversikt
Detaljert beskrivelse
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Jianzhong Zhang
- Telefonnummer: 010-88325472
- E-post: rmzjz@126.com
Studer Kontakt Backup
- Navn: Ping Liu
- Telefonnummer: 010-88325472
- E-post: llppliuping@126.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100044
- Rekruttering
- Peking University People's Hospital
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Ta kontakt med:
- Ping Liu
- Telefonnummer: 010 88325472
- E-post: llppliuping@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Exclusion Criteria:
- No.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy
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Ingen inngrep
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
Tidsramme: At Month 12
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Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
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At Month 12
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Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
Tidsramme: At Month 12
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Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
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At Month 12
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Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
Tidsramme: At Month 12
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Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
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At Month 12
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Patient-reported disease control after Atopic Dermatitis therapies in real life
Tidsramme: At Month 12
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Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
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At Month 12
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Patient-reported quality of life after Atopic Dermatitis therapies in real life
Tidsramme: At Month 12
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Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
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At Month 12
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The Atopic Dermatitis related economic burden
Tidsramme: At Month 12
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Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
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At Month 12
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jianzhong Zhang, Peking University People's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SGZ-2020-12888
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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